Female condoms

INTRODUCTION

The female condom covers the cervix, lines the vagina and shields the introitus, thus providing a physical barrier between male and female genitalia and secretions during sexual intercourse. It is designed to protect against both pregnancy and sexually transmitted infections (STIs), and is available without prescription. No contraindications exist to its use, but it may not be appropriate for women who are not comfortable touching their genitals or who may have other problems with insertion. Female condoms account for less than 1 percent of condoms produced globally [1].

FEMALE CONDOMS

All female condoms currently available or in development have an anchor (eg, ring, frame) outside the vagina to prevent the condom from being pushed inside the vagina during use; the anchor is also used for removing the condom. Female condoms have been made out of natural rubber latex, synthetic latex (nitrile), and polyurethane. They prevent preejaculatory fluid and semen from entering the vagina. No spermicide is required, but a lubricant is often needed.

The FC1 (Reality®, Femy®, Care Contraceptive Sheath®, Femidom®) was the first condom marketed to women, but is no longer in production. It was a soft, loose-fitting polyurethane sheath or pouch with two flexible polyurethane rings. One ring was contained within the closed end of the sheath and served as an insertion mechanism and internal anchor. The other ring formed the external, open edge of the device; it remained outside the vagina after insertion. Silicone-based lubricant lined the inside of the condom, but additional lubrication for the inside and/or outside could be used. The condom was about 17 cm (6.5 inches) in length (similar to a male condom). The expiration date was five years from the date of manufacture.

Variations to the FC1 have been developed. Most widely available today, the FC2 replaced the FC1 and is similar in design, but made of nitrile and without a seam. In comparative trials, it performed as well as the FC1 in terms of patient satisfaction, breakage, slippage, and invagination (ie, when the outer frame of the condom pushes into the vagina during intercourse) [2,3]. No data on pregnancy prevention or STI prevention are available, but effectiveness is assumed to be similar to the FC1 given the similar design, specifications, and functionality. The FC2 is indicated for preventing pregnancy, HIV/AIDS, and other sexually transmitted infections [4]. It may make less noise during intercourse than the FC1 and is projected to be cheaper when mass produced. It is available in about 100 countries. It has been approved by United States Food and Drug Administration (FDA); has CE Marking, which certifies that the device meets consumer safety standards and can be marketed in countries in the European Union; and has been cleared by the World Health Organization (WHO) for purchase by United Nations agencies.

The Program for Appropriate Technology in Health (PATH) Woman's Condom (WC) is another recently developed female condom [5]. It is made of polyurethane and inserted using an insertion capsule, which dissolves after insertion and releases the condom. Hydrophilic areas on the condom allow it to cling lightly to the vaginal wall and keep it in place. It is not prelubricated, but is sold with a water-based lubricant [6]. The WC was granted CE Marking in 2010. To support market registration in China, a single-arm couples’ use study was conducted to assess WC performance and safety. The study showed levels of functionality consistent with condom performance data from other female condoms [7].